FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE BELLCO FISTULA NEEDLES
K Number: K801632
·
Decision Aug 4, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
3
Review Days
20
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Basic Information
- Device Name
- THE BELLCO FISTULA NEEDLES
- K Number
- K801632
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Bellco Artifidial Organ Spec., Inc.
- Date Received
- July 15, 1980
- Decision Date
- August 4, 1980
- Product Code
- FIE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
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